Fetal Heart Rate Variability
Non-invasive Fetal Electrocardiography (NI-FECG); Repeatability of Time-domain and Spectral Analyses
1 other identifier
observational
75
1 country
1
Brief Summary
Need statement \- a new way to distinguish between a healthy small fetus and a small fetus suffering from deprivation of nutrition and oxygen to prevent unnecessary induction of preterm birth and improve neonatal outcome. Aim - to characterize fetal heart rate variability (fHRV) based on fetal ECG in the normal fetus and in the fetus suffering from growth retardation to evaluate its value and applicability as a supplementary tool in fetal surveillance. Aim of current study \- To evaluate the feasibility of NI-FECG from gestational week 20 and onwards and investigate if important factors as length and heart rate pattern affects repeatability of time domain and spectral analyses in fetuses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedNovember 23, 2020
February 1, 2020
1.7 years
February 20, 2020
November 20, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Standard deviation of normal to normal RR-interval (SDNN)
Time domain analysis, measured in ms
01.04.2020
Root mean square of successive RR-interval differences (RMSSD)
Time domain analysis, measured in ms
01.04.2020
Low frequency power (LF-power)
Spectral analysis, measured in ms\^2
01.04.2020
High frequency power (HF-power)
Spectral analysis, measured in ms\^2
01.04.2020
LF-power/HF-power
Spectral analysis, ratio
01.04.2020
Study Arms (1)
Study 2. Repeatability of FHRV
Interventions
No direct intervention, as the study is observational.
Eligibility Criteria
Danish. Healthy. Pregnant women. Expecting a healthy fetus.
You may qualify if:
- Healthy singleton pregnancies
You may not qualify if:
- Fetal malformations, multiple pregnancy, obstetric complications, maternal chronic disease and labor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
- Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundationcollaborator
- Hartmann Fondencollaborator
- Augustinus Fondencollaborator
- The Dagmar Marshall Foundationcollaborator
- AP Moeller Foundationcollaborator
- Aalborg Universitycollaborator
Study Sites (1)
Arhus Universityhospital
Aarhus, Aarhus N, 8200, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
March 27, 2020
Study Start
June 1, 2018
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
November 23, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share